Posted by Michael Wonder on 20 Feb 2023
FDA accepts Valneva’s chikungunya vaccine license application for priority review
20 February 2023 - Valneva today announced that the US FDA has completed a filing review of its biologics license application for Valneva’s single shot chikungunya vaccine candidate VLA1553 and has determined that the application is sufficiently complete to permit a substantive review.
The review classification is priority. VLA1553 has been assigned a PDUFA review goal date at the end of August 2023, which is the date by which the FDA intends to take action on the application.
